Type 2 diabetes mellitus is a chronic metabolic disease characterized by a high prevalence rate,a significant disease burden,and the need for long-term standardized management.The latest national epidemiological data reveal that in Jiangsu Province in 2023,the age-standardized prevalence of diabetes has reached 16.35%,ranking among the highest among provincial-level administrative regions in China and highlighting the severe challenges of diabetes prevention and control in Jiangsu Province.Effective pharmacological treatment is crucial for controlling blood glucose levels,delaying complications,and improving patients' quality of life.Based on the latest domestic and international authoritative guidelines for the diagnosis and treatment of adult type 2 diabetes,this consensus focuses on the selection of pharmacological treatment strategies at different stages of disease progression.It refines the medication regimens recommended in the guidelines in the form of a structured pathway,clarifies the therapeutic positioning,target populations,dosage ranges,and administration regimens of various classes of hypoglycemic drugs,while emphasizing the standardization and timeliness of pharmacological treatment.The aim is to establish a standardized pharmacological treatment pathway,bridge the gap between clinical guidelines and practice,provide clinicians with pathway-based treatment strategies,and offer solutions for rational drug use in clinical settings.
Influenza viruses are currently experiencing seasonal high activity in Hubei Province,posing a major public health threat to the population.High-risk groups,such as the elderly,children,pregnant women,patients with chronic diseases,and individuals with compromised immune systems,are more susceptible to severe complications,including respiratory failure,multi-organ dysfunction,and even death. To further standardize the clinical use of anti-influenza antiviral agents,promote their rational application medical institutions at all levels within Hubei Province,reduce the risk of antiviral resistance,and ensure the safety,effectiveness,cost-effectiveness,and appropriateness of pharmacotherapy,the Hubei Provincial Clinical Pharmacy Quality Control Center convened a multidisciplinary expert panel in influenza diagnosis and treatment and clinical pharmacy to develop the Guideline for the Rational Use of Anti-Influenza Antiviral Agents (hereinafter referred to as “the Guideline”).This Guideline was formulated based on a systematic review of the latest evidence-based medical literature,drug prescribing information,and clinical practice experience.,incorporating the epidemiological characteristics and healthcare context of Hubei Province. The Guideline applies to healthcare professionals involved in clinical diagnosis and treatment,pharmaceutical services,infection control,and related management activities across all levels and types of medical institutions in Hubei Province.It focuses on key aspects including precise indication assessment,optimal timing of administration,individualized drug selection,dosage adjustment,treatment-course management,and medication use in special populations,aiming to provide scientific,practical,and implementable guidance for clinical practice.
In 2025,the American Heart Association (AHA) released a scientific statement evaluating and managing cardiovascular and obstetric risks in patients undergoing assisted reproductive technology (ART).The statement systematically summarized the short- and long-term impacts of ART procedures on individuals with cardiovascular disease (CVD),proposed a multidisciplinary collaborative assessment framework,and emphasized optimization of treatment strategies with reproductive endocrinology and infertility (REI) specialists.It provided stage-specific management recommendations tailored to different CVD subtypes.This article synthesized the statement with international guidelines to offer clinical guidance for healthcare providers managing CVD patients undergoing ART.
Objective Anti-hepatocellular carcinoma mechanism of active peptides derived from hydrolyzates of turtle shell protein (HTSP) was elucidated by employing network pharmacology,molecular docking,and in vitro assays. Methods The study collected two active peptides from the hydrolysates of turtle shell protein (HTSP),namely HTSP-9 and HTSP-11,which were previously identified by our research group.The potential targets of these active peptides were predicted using the SuperPred and Swiss Target Prediction websites.Subsequently,the HCC-related targets were screened through databases including GeneCards,DisGeNET,and OMIM to identify the overlapping targets between the two peptides.Subsequently,Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were conducted on the overlapping targets.Cytoscape software was used to construct the HTSP-HCC-Overlapping Targets protein-protein interaction network (PPI) and screen core targets.Molecular docking experiments were performed on the HTSP and the core targets of action using AutoDock software,and finally, the network pharmacology findings were corroborated by in vitro cellular assays. Results The analysis yielded 37 core targets shared by the HTSP and HCC.The KEGG enrichment analysis involves signaling pathways such as PI3K-Akt,TNF, and apoptosis.In vitro experiments demonstrated that the HTSP could inhibit the proliferation of HepG2 cell. Conclusion The HTSPs are likely to exert therapeutic effects against HCC by modulating the growth and differentiation of hepatocellular carcinoma HepG2 cells through a multi-target and multi-pathway approach.
Objective To establish a solid phase extraction-high performance liquid chromatography (SPE-HPLC) method for the rapid determination of aconitine, mesaconitine, hypaconitine, lappaconitine, and benzoylaconine in salt-processed Aconiti Lateralis Radix Praeparata (Yan Fuzi) and rat plasma 30 min after intragastric administration of a Yan Fuzi decoction. Methods Zeolitic imidazolate framework-8 (ZIF-8) material was synthesized and characterized according to literature methods.By optimizing the preparation process of metal-organic frameworks and solid-phase extraction conditions, a quantitative analytical method coupling extraction with liquid chromatography was developed.This method was applied to detect the plasma concentrations of aconitine, hypaconitine, mesaconitine, lappaconitine, and benzoylaconine in rat plasma following intragastric administration of Yan Fuzi decoction (0.375 g·kg-1 body weight). Results The contents of five aconite alkaloids in Yan Fuzi were determined as follows:aconitine 62.78 mg·kg-1, mesaconitine 500.4 mg·kg-1, hypaconitine 37.80 mg·kg-1, lappaconitine 0.144 mg·kg-1, and benzoylaconine 36.14 mg·kg-1.In plasma samples collected 30 min post-administration, the concentrations detected were:aconitine 2.06 μg·mL-1, mesaconitine 11.79 μg·mL-1, hypaconitine 1.69 μg·mL-1, lappaconitine 1.77 μg·mL-1, and benzoylaconine 23.22 μg·mL-1.Method validation confirmed that all parameters met quantitative determination requirements. Conclusion The established method enables accurate quantification of aconite alkaloids in both Aconiti Lateralis Radix Praeparata and plasma samples after oral administration, providing a valuable reference for clinical monitoring of these compounds in biological matrices.
Objective To investigate the tacrolimus concentrations in spontaneous type 2 diabetic db/db mice plasma. Methods Eighteen db/db mice were allocated to the db/db group,and eighteen db/m mice with an identical genetic background were assigned to the db/m group.Both groups received intragastric administration of tacrolimus (10 mg·kg-1,twice daily) for three consecutive days.Tacrolimus concentrations in whole blood were measured at 2 hours (C2 h),4 hours (C4 h),and 12 hours (C12 h).The protein expression levels of CYP3A11 in the liver and jejunum of both groups were compared using Western blot analysis. Results Compared with the db/m group,the fasting blood glucose levels and the area under the glucose tolerance curve in the db/db group mice were significantly elevated (P<0.01).Additionally,the fasting plasma insulin (INS),glucagon-like peptide-1 (GLP-1),and peptide tyrosine tyrosine (PYY) levels were markedly reduced (P<0.05).Hematoxylin and eosin (HE) staining revealed a decreased number of islet cells and the presence of numerous cytoplasmic vacuoles.Insulin immunohistochemical analysis demonstrated a significant reduction in insulin staining intensity (P<0.01).Furthermore,compared with the db/m group,tacrolimus concentrations in the db/db group mice at C2 h and C4 h were significantly higher (P<0.05),increasing by 2.19-fold and 0.47-fold,respectively,while the area under the blood concentration-time curve increased 0.98-fold.The expression of CYP3A11 protein in the liver and jejunum of the db/db group mice was substantially lower than that in the db/m group (P<0.05),decreasing by 32.12% and 38.50%,respectively. Conclusions The exposure of tacrolimus was found to increase in spontaneously type 2 diabetic mice (db/db mice),while the metabolic rate decreased.This phenomenon may be attributed to the reduced expression of CYP3A11 protein observed in db/db mice.
Objective To investigate the therapeutic effects of Sijunzi decoction on dextran sulfate sodium (DSS)-induced colonic lesions in mice. Methods The aqueous extract of Sijunzi decoction was prepared via water decoction,and its polysaccharides were isolated using ethanol precipitation and the Sevag method.The purity,molecular weight,and monosaccharide composition of the polysaccharides were analyzed via high-performance liquid gel chromatography and gas chromatography-mass spectrometry (GC-MS).Mice were divided into normal,model,positive drug control (mesalazine,0.1 g·kg-1),aqueous extract (5 g·kg-1 and 15 g·kg-1,based on raw herb weight),and polysaccharide (0.18 g·kg-1 and 0.53 g·kg-1,equivalent to raw herb doses of 5 g·kg-1 and 15 g·kg-1) groups.Except for the normal group,modeling mice were administered 3% DSS in drinking water for 7 days to induce colitis (with concurrent oral treatments).Disease Activity Index (DAI) scores were assessed on day 4. On day 8,animals were anesthetized and sacrificed,and their colon length,mass,mass-to-length ratio,macroscopic and histopathological injury scores were measured.Immunohistochemistry was used to evaluate colonic protein expression levels. Results Sijunzi decoction polysaccharides were heteropolysaccharides with a relative molecular mass of approximately 4881 Da,composed of glucose (79.06%),galactose (9.49%),arabinose (7.37%),and minor monosaccharides.Both the aqueous extract and polysaccharides reduced DAI scores,macroscopic and histopathological damage,alleviated colon shortening and weight gain,and restored the decreased expression of colonic HuR,E-cadherin,Rac1,and Cdc42 proteins induced by DSS. Conclusion The aqueous extract and polysaccharides of Sijunzi decoction exert protective effects against DSS-induced colonic lesions in mice,likely mediated by upregulating colonic HuR,E-cadherin,Rac1,and Cdc42 protein expression.
Objective To investigate the mechanism of Jinkui Shenqi pill (JKSQ) in alleviating vascular calcification in chronic kidney disease (CKD) via the Phosphatidylinositol 3-kinase (PI3K)/Protein Kinase B (AKT)/Mammalian Target of Rapamycin (mTOR) signaling pathway. Methods A rat model of CKD with vascular calcification was established by intragastric administration of adenine combined with a high-phosphorus diet for 6 weeks.SD rats were randomly divided into six groups:control group,model group,calcitriol group,and JKSQ high-,medium-,and low-dose groups (n=12 per group).After successful modeling,the groups received respective interventions for 4 weeks:the model and control groups received an equal volume of normal saline;the treatment groups received high-,medium-,or low-dose JKSQ or calcitriol via gavage.Serum levels of creatinine (Cr),urea nitrogen (BUN),phosphorus,and tissue calcium were measured.Pathological changes in the abdominal aorta were observed,and the expression of key proteins in the PI3K/AKT/mTOR signaling pathway was detected. Results Compared with the control group,the model group showed significantly increased serum Cr,BUN,phosphorus,tissue calcium levels,and the formation of abdominal aortic calcified plaques,indicating successful modeling.JSP treatment dose-dependently ameliorated these indicators and alleviated vascular calcification.The medium- and high-dose JKSQ groups showed significantly superior effects compared to the low-dose group.Notably,the high-dose JKSQ group was comparable to the calcitriol group in reducing Cr levels,whereas calcitriol had no significant effect on serum phosphorus and tissue calcium.Mechanistic studies revealed that JKSQ dose-dependently up-regulated the protein expression of PI3K,p-AKT,and p-mTOR in the abdominal aorta. Conclusion JKSQ may alleviate vascular calcification in chronic kidney disease by activating the PI3K/AKT/mTOR signaling pathway.
Objective To explore the effect of different proportions of Alpinia officinarum and Cyperus rotundus compatibility on gastrointestinal motility based on orthogonal design,and to study the compatibility law of Alpinia officinarum and Cyperus rotundus,so as to provide a scientific basis for the clinical application of the drug pair. Methods Based on the classic formula design of Alpinia Officinarum and Cyperus rotundus,different ratios and doses were tested based on orthogonal experimental design.By monitoring the defecation and bead expulsion of normal and constipated mice,as well as the small intestine propulsion rate and gastric emptying rate,the analytic hierarchy process combined with criteria importance through intercriteria correlation (AHP-CRITIC) method was used to comprehensively evaluate the effects of different combinations.The optimal combination ratio and dose were selected based on the orthogonal design method. Results Different combinations of Alpinia officinarum and Cyperus rotundus exhibited distinct effects.Using the AHP-CRITIC method,it was found that in terms of regulating gastrointestinal motility,Alpinia officinarum was more significant than Cyperus rotundus.The top three combinations were Alpinia officinarum and Cyperus rotundus 2:1 (5.4 g·kg-1) group,Alpinia officinarum (5.4 g·kg-1) group,and Alpinia officinarum and Cyperus rotundus 1:1 (10.8 g·kg-1) group.Their comprehensive scores are 81.21,80.64 and 78.54,respectively. Conclusion The experiments proved that the optimal ratio of Alpinia officinarum and Cyperus rotundus is 2:1,which provides a reference for further in-depth research and clinical application of this herb couples.
Objective To investigate the effects and molecular mechanisms of Shaoyao decoction (SYD) on colorectal cancer (CRC) using network pharmacology and in vitro experiments. Methods Information on SYD active components and targets was retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP) and the Swiss Target Prediction online platform.Targets associated with CRC were obtained from the Therapeutic Target Database (TTD) ,Online Mendelian Inheritance in Man (OMIM) ,GeneCards,and DrugBank databases.A drug-active ingredient-disease target network was then constructed.The intersection was analyzed using Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses.Molecular docking was performed.Eight-week-old male Sprague-Dawley rats were dosed with SYD (24 g·kg-1,twice daily) by gavage.The SYD drug-containing serum was prepared.HT29 cells were assigned to four groups:control group (the blank serum),low-dose SYD-medicated serum (SYD-L),medium-dose SYD-medicated serum (SYD-M),and high-dose SYD-medicated serum group (SYD-H).After treatment with 0,5%,10%,and 20% SYD-medicated serum,cell proliferation was assessed using CCK-8 assays and cell migration by scratch assays.The expression levels of the epithelial-mesenchymal transition (EMT) markers (E-cadherin,N-cadherin,and Vimentin) and phosphatidylinositol 3-kinase/protein Kinase B (PI3K/AKT) pathway-related proteins were analyzed by Western blotting. Results The potential core targets of SYD in treating CRC were found to be AKT1,PIK3CA,etc.KEGG pathway enrichment analysis identified the most significant signaling pathway was PI3K/AKT.Molecular docking showed that the key active components bound stably with high affinity to the target AKT1.Cell-based assays demonstrated that treatment with SYD-M and SYD-H significantly suppressed cell proliferation and migration compared to the Control group.Consistent with these findings,Western blotting analysis revealed a significant increase in E-cadherin expression and marked decreases in the levels of N-cadherin and Vimentin,as well as in the p-PI3K/PI3K and p-AKT/AKT ratios in the corresponding treatment groups (P<0.05). Conclusion SYD can inhibit the proliferation and migration of CRC cells,in which the regulation of the PI3K/AKT signaling pathway to inhibit the EMT process is a major contributor.
Hepatocellular carcinoma (HCC) is highly prevalent worldwide and is also a major health and hygiene issue affecting Chinese people.Tumor vaccines,as an innovative immunotherapeutic approach,have introduced promising prospects for the treatment of HCC.This article conducts a comprehensive review of the related research on tumor vaccines and the treatment of HCC,covering aspects such as basic theories,diagnostic techniques,treatment strategies,technological progress,as well as controversies and challenges,aiming to deeply explore the current application status and development prospects of tumor vaccines in the treatment of HCC,with the expectation of providing references for basic and clinical practice.
In recent years,significant progress has been made in immunotherapy,particularly with immune checkpoint inhibitors (ICIs),such as programmed cell death protein-1 (PD-1) inhibitors,programmed death ligand-1 (PD-L1) inhibitors,and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors,which have transformed the treatment landscape for solid tumors.Among these,multiple PD-1/PD-L1 inhibitors have been approved for the treatment of early,locally advanced,and advanced non-small cell lung cancer (NSCLC).However,immunotherapy is often accompanied by drug resistance and immune-related adverse events (irAEs).Targeting other immune checkpoints to modulate the tumor microenvironment represents a promising strategy to overcome the limitations of current ICIs.These include lymphocyte activation gene-3 (LAG-3) antibodies,T cell immunoglobulin and ITIM domain (TIGIT) antibodies,T cell immunoglobulin and mucin-domain containing-3 (TIM-3) antibodies,bispecific antibodies,and combination antibodies.Most of these agents targeting alternative immune checkpoints have entered clinical trials and demonstrated certain efficacy.This review will focus on the advances in major ICIs beyond PD-1/PD-L1 inhibitors,as well as bispecific antibodies and combination antibodies,in the context of NSCLC.
Oncolytic viruses, as a targeted immunotherapy approach for tumors, have garnered significant attention in recent years. In this review, we systematically summarize the research progress and application prospects of oncolytic viruses, outline their mechanisms of action, and discuss strategies for their genetic engineering as well as the advantages of combining them with other treatment modalities. We also address the challenges in clinical translation, such as safety, targeting efficiency, and immunogenicity. This review argues that oncolytic viruses hold future development potential in areas such as synthetic biology, AI-assisted design, and multimodal combination therapies, providing a theoretical foundation for their emergence as a key approach in next-generation tumor immunotherapy.
Bispecific antibodies (BsAbs) theoretically offer enhanced specificity,superior efficacy,and reduced off-target effects by simultaneously targeting two distinct antigens or two epitopes of the same antigen.Through mechanisms including immune cell recruitment/activation,dual-target signal blockade,and tumor microenvironment modulation,BsAbs have demonstrated significant anti-tumor potential in both solid tumors and hematologic malignancies,holding promise for advancing tumor treatment toward greater precision and personalization.This review summarizes the classification,mechanisms,and clinical trials of BsAbs in solid tumors,and discusses current challenges in the field,aiming to provide a theoretical foundation and practical reference for the clinical application of BsAbs in solid tumor therapy.
Chimeric antigen receptor natural killer (CAR-NK) cell therapy has emerged as a promising immunotherapeutic strategy for solid tumors,demonstrating distinct advantages over chimeric antigen receptor T (CAR-T) cell therapy.Compared to CAR-T cells,CAR-NK cells exhibit innate antitumor activity,multiple cytotoxic mechanisms,superior safety profiles,and diverse cell sources.Currently,more than 30 clinical trials worldwide are investigating CAR-NK applications in solid tumors,with preliminary successes observed in multi-target approaches against NKG2D,ROBO1,and other targets.However,significant challenges remain,including the immunosuppressive tumor microenvironment (TME),inadequate NK cell infiltration,and limited persistence.Combination strategies,particularly synergistic approaches with radiotherapy,have shown potential to enhance therapeutic efficacy.Future research should focus on optimizing CAR designs and developing novel combination regimens to overcome current limitations in solid tumor treatments and provide more effective treatment options for patients with solid tumors.
Driven by the global momentum of precision medicine,pharmaceutical care is transitioning from fundamental medication supply to comprehensive patient lifecycle health management.The international scholarly community employs multidisciplinary theories and methods to investigate the scientific evaluation and value quantification of pharmaceutical care.Propelled by authoritative monographs,this has established Pharmacy Practice Research——a modern research paradigm centered on patient health outcomes and grounded in methodological rigor.An international consensus on its core definition and research scope has emerged through scholarly discourse,establishing it as a vital branch of health services research.This field focuses on evidence-based inquiry into medication use,patient monitoring,and practice-related challenges within healthcare systems.This article draws on global research advancements and logico-analytical methodologies to systematically elucidate the definition and research scope of Pharmacy Practice Research.Employing a clinical-economic-humanistic value assessment framework,it further explores the critical role of Pharmacy Practice Research in enhancing rational medication use,optimizing healthcare resource allocation,and improving patient behavior adherence.This thereby provides theoretical foundations and practical insights for developing pharmaceutical care systems tailored to the Chinese healthcare context.
In recent years,with the evolution of pharmaceutical service models,the value of pharmaceutical practice research in optimizing clinical medication decisions and improving the quality of pharmaceutical services has become increasingly evident.Currently,the three main research methods commonly used in this field are quantitative study,qualitative study,and mixed-methods study,reflecting a trend toward methodological diversity.However,in practice,there are still issues such as insufficient depth of interpretation in qualitative research and a lack of a systematic integration framework in mixed-methods research.This paper systematically reviews the core characteristics and applicable scenarios of the aforementioned three methods,focusing on analyzing the application logic of grounded theory and explanatory sequential design in pharmaceutical practice scenarios,such as medication adherence mechanism analysis and interprofessional collaboration intervention effectiveness evaluation.It combines typical cases to clarify the applicable boundaries and integration strategies for method selection.The study found that qualitative research can deeply reveal the cultural and social structural drivers behind patients' medication behaviors,while mixed-method research has unique advantages in constructing a "quantitative-qualitative validation--mechanism explanation" research loop.There is an urgent need to strengthen standardized construction in data integration and methodological collaboration.This paper helps guide researchers in achieving systematic thinking from problem definition to method selection,thereby enhancing the scientific rigor,applicability,and translational value of pharmaceutical practice research.
Objective To systematically sort out the current application status of behavioral theory and models in pharmaceutical practice research,summarize the commonly used behavioral theory,model,framework,and its application characteristics,explore its role and value in pharmaceutical practice,and provide direction guidance for future research. Methods The scoping review method was used to search all pharmacy practice related articles using behavioral theories or models in Web of Science,PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure,Wanfang Data Knowledge Service Platform,Weipu.com,and China Biomedical Database.The search period was to be established until March 31,2025.Two researchers independently summarized,screened,classified,and analyzed the included literature data. Results A total of 1 669 documents were retrieved,and 110 were finally included.Through literature analysis,five high-frequency theoretical models in pharmaceutical practice were extracted,namely TPB,TTM,COM-B,HBM,and SCT.There are certain differences in common theoretical models and topics in domestic and foreign research.Most studies use a single theoretical model.Among the studies using multiple theories,the most common combinations abroad are COM-B and TDF,and the most common combinations in China are TPB and TTM.Most of the studies belong to the first two stages in the UK MRC complex intervention research framework.Foreign researchers are mainly pharmacy professionals and health management departments,while Chinese researchers are mainly nursing staff,followed by pharmacy staff. Conclusions Compared with more mature and extensive research abroad,pharmaceutical practice research in China is still in its infancy.Few domestic pharmacy researchers apply theoretical models to all aspects of pharmaceutical practice.It is necessary to learn from international experience,clarify research issues and select appropriate theoretical models,improve the effectiveness and sustainability of pharmaceutical services while improving the scientificity and practicality of research,and promote the vigorous development of domestic pharmacy practice research.
Objective To analyze the literature related to the study of international pharmacy practice based on Web of Science by using CiteSpace,to discuss the hotspots and development trends of the study of international pharmacy practice,and to provide a reference for our country. Methods Data extraction was conducted in the Web of Science Core Collection database,and literature from January 2020 to March 2025 was retrieved.The CiteSpace software was used for bibliometric analysis,and a visualization map was drawn. Results A total of 7 589 literatures were included.The number of articles published in the past five years remained at about 1400.The representative fields of keyword clustering include medication safety,medication errors,medication reconciliation, and so on. Conclusions International pharmacy practice research focuses on medication adherence,medication reconciliation,medication safety, and community pharmacy service.China needs to draw on the hotspots and trends of international pharmaceutical practice research and build an innovative pharmacy practice system.
Tetrahydrobiopterin,as an important coenzyme of aromatic amino acid hydroxylase,is involved in the metabolism of amino acids in the body.Based on that mechanism,the drug sapropterin hydrochloride tablet has been approved for the treatment of patients with hyperphenylalaninemia.In recent years,with the further research on the application of the drug,it has been found that sapropterin hydrochloride tablets can effectively reduce the concentration of phenylalanine in patients with hyperphenylalaninemia,improve the symptoms of patients with hyperphenylalaninemia,and reduce the risk of complications.But its long-term safety still needed further studies and evaluation.At present,there are relatively few studies on sapropterin hydrochloride tablets as an alternative to tetrahydrobiopterin in the treatment of hyperphenylalaninemia in China.This review aims to integrate relevant studies at home and abroad to provide a reference for the clinical application of sapropterin hydrochloride tablets.
Objective To investigate the compatibility of imipenem-cilastatin sodium with two total nutrient admixtures when mixed via a Y-site infusion channel and evaluate their co-administration feasibility. Methods Simulating clinical practice conditions.IMI-CIL was combined with two total nutrient admixtures at three volume ratios (1:1,2:1,and 4:1).The mixtures were stored at room temperature [(25±2) ℃] for 4 hours.The appearance,pH,osmolality,insoluble particles,emulsion particle size,and zeta potential of the mixtures were investigated at time points of 0,0.5,1,2 and 4 hours.The contents of imipenem and cilastatin were also determined by HPLC. Results After 4 hours of storage,no significant changes were observed in the appearance,pH,osmolality,insoluble particles,MDD,PDI,and zeta potential of each group.The addition of IMI-CIL to total nutrient admixture caused an increase in pH and a decrease in osmolality and zeta potential,but there was no significant effect on the MDD and PDI of fat emulsion.The relative percentages of cilastatin were all higher than 93% within 4 hours.Imipenem was higher than 90% within 4 hours only in the 4:1 dosing volume ratio and within 1 hour only in the 1:1 and 2:1 dosing volume ratios. Conclusions IMI-CIL can be co-administered with two total nutrient admixtures via Y-site infusion channels.However,when the infusion rates of IMI-CIL and total nutrient admixtures are comparable,their contact time in the infusion channels should not exceed 1 hour.
Objective To investigate the current situation and identify the risk factors of vancomycin-associated acute kidney injury (VA-AKI) in elderly patients,as well as to comprehensively examine the risk related to concurrent drug use.Further,we examined the outcomes of VA-AKI patients and risk factors for these outcomes.We aimed to provide suggestions for the clinical rational use. Methods We conducted a retrospective study of the medical records of elderly patients who had been treated with VAN from January 2016 to December 2019.The patients were divided into the AKI group and the non-AKI group.The risk factors of VA-AKI were analyzed using the multivariable logistic regression model. Results Of 1 320 elderly patients,195 developed VA-AKI (14.8%).31.7% of the patients received therapeutic drug monitoring (TDM) during VAN treatment.Logistic regression analysis showed that the baseline eGFR [Odds ratio (OR)=1.003,P=0.048],liver dysfunction (OR=4.721,P=0.000),shock (OR=2.889;P=0.033),mechanical ventilation (OR=1.925,P=0.003),length of VAN therapy (OR=1.033,P=0.016),concomitant use of vasopressors (OR=2.030,P =0.006),Piperacillin and tazobactam (PTZ) (OR=3.525,P=0.016) and Proton pump inhibitors(PPIs) (OR=2.121,P =0.003) were independent risk factors for VA-AKI.Further analysis showed that the incidence of mortality in VA-AKI patients was 27.2% (53/195). 46.2%(90/195) of VA-AKI patients had recovered or improved in renal function after discharge.Multivariate logistic regression showed that the use of radio-contrast agents and admission to the intensive care unit (OR=2.959,P=0.020;OR=2.909,P=0.013) were independent risk factors influencing the outcomes of VA-AKI. Conclusion Patients using VAN received insufficient therapeutic drug monitoring.The lower baseline eGFR,liver dysfunction,severe illness,a long VAN therapy,concomitant use of vasopressors,PTZ,and PPIs would increase the risk of VA-AKI in elderly patients.
Objective Seven anaplastic lymphoma kinase-tyrosine kinase inhibitors (ALK-TKIs) were evaluated comprehensively by a quantitative assessment method,thereby providing a reference for drug selection for medical institutions. Methods Based on the Expert Opinion on Drug Selection and Transfer Mechanism for Medical Institutions in Hubei Province,seven ALK-TKIs were objectively evaluated by a quantitative scoring system.Recommendation levels were defined according to the scores. Results The final scores were: alectinib (71.7),crizotinib (70.1),lorlatinib(69.9),ensartinib (68.3),ceritinib (68.0),brigatinib (67.8), and iruplinalkib (58.9). Conclusion Alectinib and crizotinib were recommended as "strong recommendation" when medical institutions introduced ALK-TKIs for advanced non-small cell lung cancer (NSCLC).Lolatinib,ensartinib,ceritinib, and brigatinib all scored more than 60 points.Medical institutions could decide whether to introduce them according to the characteristics of the patient population and the availability of alternative drugs.
Objective To develop a perinatal medication risk prediction model based on the XGBoost algorithm and to evaluate its clinical value and practical feasibility in pharmaceutical care. Methods A retrospective analysis of 1101 patients with periconceptional counselling in the pharmacy clinic of the Fifth Hospital of Wuhan City from July 2020 to June 2024.A total of 31 variables,including demographic data,disease characteristics,and medication information,were collected.Multivariate Logistic regression was used for the preliminary screening of risk factors.An XGBoost medication risk prediction model was developed and validated.The SHAP (SHapley Additive exPlanations) method was used to analyze feature importance.Patients were stratified into low,medium,and high-risk groups based on predicted probabilities,and a comparative analysis with traditional models was performed. Results Advanced maternal age (≥35 years) (OR=1.85),gravidity ≥3 times (OR=1.68),history of comorbid chronic diseases (OR=2.15),and drug exposure in early pregnancy (OR=1.92) were identified as independent risk factors.The XGBoost model demonstrated high predictive performance on the test set (AUC=0.87,sensitivity=0.85,specificity=0.82).SHAP analysis indicated that advanced maternal age had the largest risk contribution.Following risk-stratified intervention,medication adherence and the efficiency of pharmaceutical management were significantly improved in the high-risk group. Conclusions The XGBoost algorithm,combined with the SHAP method,can accurately predict perinatal medication risk.This provides clinical pharmacists with a reliable risk assessment tool and shows promising prospects for clinical application.
A 62 year old male patient received longterm use of warfarin 3 mg once daily orally after the operation of aortic mechanical valve replacement,and the international normalized ratio (INR) was maintained at 1.80-2.50.The patient was treated with sodium aescinate 60 mg twice daily due to varicose veins of the lower extremities with ulceration,and developed gingival bleeding three days later,INR was 6.50.Warfarin was discontinued and the dose of sodium aescinate was reduced to 30 mg orally once daily,and administer vitamin K1 therapy.Four days of drug withdrawal,warfarin doses of 1.5 mg·d-1 and 2.25 mg·d-1 alternatively,INR was 1.87 to 2.43.It was considered that the abnormally elevated INR was caused by the interaction between warfarin and sodium aescinate.
The patient,male,32 years old,was given 45 mg of upadacitinib tablets qd for ulcerative colitis.He developed drug fever after oral administration.The occurrence,diagnosis,treatment,and follow-up of the adverse drug reactions were retrospectively analyzed.The correlation between upadacitinib and adverse drug reactions was evaluated,and the possible mechanism of the adverse drug reactions was discussed through literature analysis.This case of adverse drug reactions is rare.We suggested that the monitoring of the adverse reactions of drug fever should be strengthened to ensure the safety of the clinical use of upadacitinib.
Objective To develop methods for evaluating drug effectiveness and safety based on real-world data. Methods A methodological framework encompassing data collection,extraction,governance,and evaluation for real world data (RWD)-based comprehensive clinical drug evaluation was constructed,with an innovative approach of multi-dimensional subgroup analysis proposed.For unstructured texts such as medical records,a “label-model-review” mode was adopted to convert them into structured data.Machine learning algorithms were applied to predict and impute missing case outcomes.Key factors influencing outcome indicators were identified through multi-factor analysis,and patients were stratified into multiple subgroups based on these factors to evaluate different drug varieties/formulations within each subgroup.The above methods were empirically applied to evaluate the efficacy and safety of tandospirone capsules and tablets. Results A total of 12 265 inpatients and 144 483 outpatients were included.The AUC values of the anxiety level prediction models all exceeded 0.9.The effective rates of tandospirone capsules and tablets at (30±10) days and (60±20) days of treatment were 93.40% vs.91.64%,93.44% vs.92.87%,respectively.Among 905 efficacy-evaluated subgroups,capsules demonstrated superior effectiveness to tablets in 642 subgroups (70.94%),with only 66 subgroups (7.29%) showing the inverse pattern.Safety analyses revealed the ADR incidence with capsules was 1.53%,which was lower than the 1.63% for tablets,with no statistically significant difference.This advantage persisted in 363/439 safety subgroups (82.69%),whereas tablets showed lower risk in merely 17 subgroups (3.87%). Conclusions The study demonstrates the significant advantages of applying machine learning and artificial intelligence technologies in the cleaning and structuring of real-world data.The developed machine learning-assisted evaluation framework enables precise identification of differences in the relative effectiveness and safety of drugs across patient subpopulations,providing a methodological reference for real-world evidence-based drug evaluation practices.
Objective To understand the informatization management status of narcotic and psychotropic drugs in secondary and above medical institutions in Jiangsu Province,and to provide a decision-making basis for improving the management level of narcotic and psychotropic drugs in medical institutions. Methods A questionnaire was designed,taking 77 secondary and above medical institutions in Jiangsu Province as the research objects.The personnel in charge of the pharmacy departments of these institutions were responsible for filling out the questionnaire.The survey covered the following aspects: basic information of the respondents; their awareness and attitude towards the informatization management of narcotic and psychotropic drugs; the allocation of software and hardware facilities for such management; the internal circulation management of these drugs within medical institutions; the informatization management of prescription issuance and drug compounding; the monitoring of drug abuse and patient management; and the existing problems and suggestions for the management of narcotic and psychotropic drugs.Finally,a descriptive statistical analysis was performed on the survey results. Results A total of 102 questionnaires were distributed and 102 valid ones were returned.Of the respondents,92.2% were engaged in work related to the management of narcotic and psychotropic drugs.The main problems in the informatization management of narcotic and psychotropic drugs in secondary and above medical institutions in Jiangsu Province currently include: insufficient understanding of these drugs by managers; low intelligence level of management equipment; lack of standardized and standardized informatization management; and absence of control measures for potential drug abusers. Conclusion Although preliminary achievements have been made in the informatization management of narcotic and psychotropic drugs in secondary and above medical institutions in Jiangsu Province,there is still a need to enhance the awareness of medical staff,promote the monitoring and reporting of drug abuse,and accelerate the standardization and normalization of the informatization management of narcotic and psychotropic drugs.